Category: Covid-19 Vaccine

FILE - A man walks by Pfizer headquarters, Friday, Feb. 5, 2021, in New York. Pfizer reports their earnings on Tuesday, Jan. 30, 2024. (AP Photo/Mark Lennihan, File)

(NewsNation) The state of Kansas has sued the pharmaceutical company Pfizer, accusing it of misleading the public about its COVID-19 vaccine by making false claims about its effectiveness.

Inthe lawsuitfiled Monday, Republican Attorney General Kris Kobach claims Pfizer misled Kansas residents by claiming the vaccine was safe and hid evidence of the shots link to myocarditis and pregnancy issues.

Pfizer made multiple misleading statements to deceive the public about its vaccine at a time when Americans needed the truth, he said in a statement.

Watch Kansas Attorney General Kris Kobach discuss the lawsuit on CUOMO on June 20 at 8p/7C. Find your channel here.Getfactbased,unbiased newscoverage 24/7 with theNewsNation app.

Kobach claims Pfizers alleged false statements violated the Kansas Consumer Protection Act. The state is seeking unspecified monetary damages.

Millions of Kansans heard Pfizers misrepresentations about its COVID-19 vaccine, according to the suit.

The complaint alleges Pfizer earned record company revenue of approximately $75 billion in just two years through its misrepresentations of the vaccine.

For example, Pfizer administered 3,355,518 Pfizer vaccine doses in Kansas as of February 7, 2024.This accounted for more than 60% of all vaccine doses in Kansas, the suit alleges, citing Kansas Department of Health Data.

Additionally, the complaint claims Pfizer gave residents a false impression when it claimed its vaccine was effective, but knew the shot waned over time and did not protect against COVID-19 variants.

The U.S. Food and Drug Administration in 2021added a warningabout myocarditis and pericarditis, both rare heart inflammation conditions, to Pfizer and Modernas COVID-19 vaccines.

COVID-19 vaccine studies conducted last year by the National Institutes of Health found no evidence the shots are linked to an increased risk of miscarriage.

In a statement to The Hill, Pfizer claims the case has no merit and plans to respond to the lawsuit in due course.

We are proud to have developed the COVID-19 vaccine in record time in the midst of a global pandemic and saved countless lives. The representations made by Pfizer about its COVID-19 vaccine have been accurate and science-based, the company said.

Kobachs lawsuit comes as a new study discovered possible links betweenCOVID-19 vaccinesand possible neurological, blood and heart-related conditions.

The new study is the largest of its kind since the pandemic began and could reignite the debate over the risks and benefits of the vaccine.

Additionally, the complaint follows a similar lawsuit filed last year by Texas Attorney General Ken Paxton, which claims Pfizer misled the public when it claimed the shot was 95% effective. The case is pending.

Over the past three years, more than 13.5 billion doses ofCOVID-19 vaccineshave been administered around the world. The World Health Organization recently announced vaccination has saved at least 1.5 million lives in Europe alone.

More than 366 million doses of Pfizers original BioNTech COVID-19 vaccine were administered in the U.S.

NewsNations correspondent Nancy Loo and The Hill contributed to this report.

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Kansas sues Pfizer over alleged misrepresentation of COVID vaccine - NewsNation Now

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Kansas sues Pfizer over COVID vaccine development and marketing - BenefitsPro

Recovery by 90 days was tied to pre-infection vaccination (hazard ratio [HR], 1.30) and infection during the Omicron variant wave (HR, 1.25). These associations were mediated by less severe infection by 33.4% and 17.6%, respectively. Risk factors for long COVID, or post-COVID condition (PCC) were female sex (HR, 0.85) and pre-existing cardiovascular disease (HR, 0.84). The results were similar for reinfections.

"Our study underscores the important role that vaccination against COVID has played, not just in reducing the severity of an infection but also in reducing the risk of long COVID," lead author Elizabeth Oelsner, MD, MPH, said in a Columbia Universitypress release.

"Our study clearly establishes that long COVID posed a substantial personal and societal burden," she added. "By identifying who was likely to have experienced a lengthy recovery, we have a better understanding of who should be involved in ongoing studies of how to lessen or prevent the long-term effects of SARS-CoV-2 infection."

Noting the propensity for American Indian or Alaska Native participants to have prolonged recoveries in models that didn't account for cohort effects, the authors said more research is needed on how much the pandemic may have worsened US social and health disparities, including among Indigenous populations.

"Inclusion of racially and ethnically diverse participants in PCC mechanistic research and clinical trials remains essential to identifying and equitably distributing interventions," they wrote.

Likewise, women had slower recoveries despite a lower rate of severe infection. "Sex differences in risk of PCC, and particularly PCC subphenotypes characterized by neurologic, musculoskeletal, and autoimmune conditions, could be explained by multiple mechanisms, including differences in the immune response and higher risk of autoreactivity and thrombosis in women (vs men),that merit further study," the researchers wrote.

"Further investigation on the longer-term prognosis and mechanisms of PCC, including comparisons of multiorgan structure and function before and after infection, is critical to inform treatment and prevention," they concluded.

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Study identifies female sex, heart disease as long-COVID risk factors, vaccination as protective - University of Minnesota Twin Cities

Novavax (NVAX Quick QuoteNVAX - Free Report) submitted an application to the FDA, seeking to amend its Emergency Use Authorization (EUA) and update its protein-based COVID-19 vaccine for the upcoming fall season.

While this updated vaccine has been formulated to target the JN.1 variant, management claims that the vaccine has also been shown to be effective against the current circulating strains, including KP.2 and KP.3.

Subject to necessary permissions from the FDA and CDC, Novavax intends to market this updated COVID-19 vaccine in pre-filled syringes by mid-August. If authorized/approved, it will be the only protein-based non-mRNA COVID-19 vaccine in the United States.

Novavaxs filing is based on guidance from the FDA issued last week, which advised COVID-19 vaccine manufacturers Moderna (MRNA Quick QuoteMRNA - Free Report) , Novavax and Pfizer (PFE Quick QuotePFE - Free Report) to update their respective COVID-19 vaccines to target the KP.2 strain if it is feasible. This guidance is an update on the FDAs prior advice issued at the beginning of this month that recommended updating the COVID-19 vaccines to target the JN.1 strain.

The FDAs prior advice was in line with the recommendation issued by a World Health Organization (WHO) advisory committee on Apr 26. However, the FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country since the end of April. The latest CDC data (as of Jun 8) shows that the KP.2 and KP.3 strains were the most prevalent, accounting for nearly half of COVID-19 cases in the country.

The KP.2 strain is a JN.1-derived subvariant that contains two new additional mutations. Per the FDA, this subvariant provides an advantage to the virus either in terms of fitness or escape from immunity.

Management is also working with other regulatory authorities across the globe to secure authorization/approval for updating its protein-based COVID-19 vaccine.

Year to date, the stock has skyrocketed 200.0% against the industrys 6.3% fall.

Image Source: Zacks Investment Research

Currently, Novavaxs COVID-19 vaccine is only authorized by the FDA for use in individuals aged 12 years and older. The FDA is reviewing the companys regulatory filing seeking full approval for the COVID-19 vaccine. A final decision is expected before April 2025.

Earlier this month, Moderna submitted an application to the FDA seeking approval of its mRNA-based COVID-19 vaccine, for the 2024-2025 fall season. Pfizer is yet to provide an update on the FDA filing for its COVID-19 vaccine.

Compared with Pfizer and Moderna, Novavax was not able to reap the benefits of the pandemic due to a delayed launch of its COVID-19 vaccine. During last years vaccination season, sales of Novavax suffered due to delayed approval of its vaccine formulation and product launch. Some investors and analysts believe that Novavaxs early participation in the upcoming vaccination season could capitalize on the opportunity.

Starting next year, Sanofi (SNY Quick QuoteSNY - Free Report) will gain rights to co-market Novavaxs protein-based COVID-19 vaccine globally. The French drugmaker will also have the sole license to develop and market the Novavax vaccine in combination with its influenza vaccine. In return, Novavax will be eligible to receive up to $1.2 billion, including $500 million in upfront payment and the rest in milestone payments. NVAX will also be eligible to receive tiered double-digit percentage royalty payments on product sales under this deal. In addition, Sanofi also agreed to make an equity investment of nearly $70 million in Novavax in exchange for a 4.9% stake.

The deal with Sanofi breathes new life into Novavax, which had been facing uncertainties in its business for a long time. With the backing of a pharma giant, Novavax expects to increase the market share and presence of its COVID-19 vaccine to a larger audience. This deal even allowed management to do away with its previous concerns about its ability to continue as a going concern.

Using the funds from the Sanofi deal, Novavax also started making plans to expand its pipeline. Alongside its first-quarter earnings, management claimed to have been developing a new approach for vaccinating against H5N1 bird flu. It is also advancing core technology for different uses like mucosal vaccination and high-density nanoparticles.

Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of todays Zacks #1 Rank (Strong Buy) stocks here.

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Novavax (NVAX) Seeks FDA Nod for Updated COVID-19 Vaccine - Zacks Investment Research

Robert Mittendorf / The Bellingham Herald (TNS)

Nearly 20 former Bellingham employees are suing the city and former Mayor Seth Fleetwood over their dismissal for refusing to get vaccinated against COVID-19.

In the lawsuit, filed Thursday with the U.S. Western District Court in Seattle, the employees are seeking unspecified punitive and compensatory damages in a jury trial.

All 18 employees, including former police officers, firefighters, mechanics and Public Works Department employees, are being represented by the Schexnaydre Law Firm of Mandeville, La., and locally by Charice Holtsclaw.

They were fired for not complying with Fleetwood's executive order, issued Sept. 21, 2021, requiring all city employees to have the COVID-19 vaccine by Dec. 6, 2021. By that time, nearly 80% of all city workers had been vaccinated, according to Bellingham spokeswoman Janice Keller.

Neither the plaintiffs' lawyers nor Bellingham officials were immediately available for comment late Tuesday.

Keller, the the city's communications director and deputy city administrator, told The Bellingham Herald in a May 1 email that Fleetwood was acting in good faith to ease the suffering and death caused by the coronavirus pandemic.

"The city's vaccine mandate was enacted as an emergency order to protect the health and safety of employees and the public, during a time when COVID-19 was causing illness, loss of life, and disruption to our community and our workforce. We took this action with great care, and with the support of many employees who were grateful for this additional protection in our workplace. When employees requested accommodations, our team evaluated each request individually and thoughtfully, understanding that their recommendations affected employees' lives and livelihoods. These were difficult decisions made during extraordinary times, with employee and public health and safety at the forefront of our minds," Keller said.

Plaintiffs in the lawsuit filed Thursday include Tawsha Thompson, a former Bellingham police officer with 25 years experience. She ran for the state House as a Republican in 2022, losing to Rep. Alicia Rule, D-Blaine.

Some of the employees who were dismissed say that their requests for medical and religious exemptions under the vaccine mandate were rejected, according to the lawsuit.

As of Dec. 7, 2021, a total of 27 city employees lost their jobs for failing to comply with state and city vaccine requirements, Keller told The Herald in April, when former police officer Joshua D. Wilson sued the city over his COVID-19 firing. Wilson was not named as a plaintiff in Thursday's lawsuit.

Six employees resigned, 17 were dismissed for violating the city's terms of employment, and four were dismissed for violating Gov. Jay Inslee's vaccination order for state employees, teachers and health care workers, such as firefighters, Keller said.

In the lawsuit the plaintiffs say that the COVID-19 vaccines were medical treatments and that they "have a fundamental right and constitutionally protected liberty interest to refuse medical treatments."

The plaintiffs claimed that the vaccines resulted in a "massively anomalous (1,000% higher) number of adverse events and deaths," and that the was no justification for the mandate because the vaccines don't prevent the infection or transmission of COVID.

Fleetwood lifted the vaccine mandate on Feb. 13, 2023.

In addition to the lawsuits, the Bellingham Police Guild, which is the union that represents Bellingham police officers, filed an unfair labor practice complaint against the city with the Public Employment Relations Commission on March 14, 2022, alleging that the city should have first bargained the union over the vaccine mandate, Keller told The Herald.

A PERC hearing examiner ruled April 26 that the city did not commit an unfair labor practice and dismissed the Guild's complaint in the attached decision. The Guild has 20 days to appeal the decision to the full commission.

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(c)2024 The Bellingham Herald (Bellingham, Wash.)

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Former employees of Washington city file class-action suit against city over COVID-19 vaccine policies | The Daily ... - Centralia Chronicle

Updated June 10, 2024

When vaccines became available, we gathered some of the most common COVID-19 vaccine questions that our health education specialists have received and answered them below. This page will be updated as necessary and will not be updated frequently.

The American College of Rheumatology (ACR) and the Centers for Disease Control and Prevention (CDC) recommend that people with lupus who meet the age requirements receive a series of COVID-19 vaccines.

The virus has changed and is now easier to catch and transmit, even for people who are vaccinated, but it is much less likely to get it or have a serious case if they are completely vaccinated. Getting vaccinated is still the best way to prevent serious illness and death from COVID-19.

If you have not gotten the vaccine and updated additional doses, please talk to your health care team about why you should receive it.

Now more than ever it is important to have a health care team that you trust. If you dont currently have a doctor who treats your lupus, or if you need a new one, we can help.

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COVID-19 vaccine and lupus - Lupus Foundation of America

(Precision Vaccinations News)

Novavax, Inc.today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1COVID-19vaccine (NVX-CoV2705) for individuals aged 12 and older.

The submission aligns with guidance from the U.S. FDA, the European Medicines Agency, and theWorld Health Organizationto target the JN.1 lineage during late 20204.

As discussed at the recent FDA meeting, targeting JN.1, the parent strain of the most common currently circulating SARS-CoV-2 virus variantshas a public health benefit.

Novavax's JN.1 vaccinehas demonstrated broad cross-neutralizing antibodiesagainst multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants.

"Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," saidJohn C. Jacobs,President and Chief Executive Officer, Novavax, in a press release on June 14, 2024.

Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses toJN.1 lineage viruses, including those containing the F456L and R346T mutations, and to "FLiRT"and "FLuQE" variants.

Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.2Novavax's updated JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.

Novavax intends to have doses in the U.S. for distribution by mid-July. Upon FDA authorization and U.S. CDCrecommendation, Novavax is preparing to deliver to U.S. customers promptly.Novavax is also working with other regulatory authorities globally to authorize or approve its JN.1 COVID-19 vaccine.

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Updated Protein-based 2024-2025 Formula COVID-19 Vaccine Preps for Distribution - Precision Vaccinations

CamiloTorres / iStockphoto

Today the Centers for Disease Control (CDC) said at least 15 people in nine states have been sickened with Salmonella linked to pet bearded dragons. Four people have required hospitalization, but no deaths have been reported.

New York has reported four cases, Ohio and California have each reported three cases, and Iowa, Texas, Oklahoma, Tennessee, North Carolina, and Georgia have each reported a single case.

"The true number of sick people in an outbreak is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses," the CDC said. The outbreak strain is Salmonella Cotham.

Illnesses started on dates ranging from January 8, 2024, to May 16, 2024. Of the 12 people interviewed, 7 (58%) reported contact with a bearded dragon before getting sick. At least one child did not report contact, suggesting he or she was likely exposed indirectly at home.

"60% of sick people are children under 5 years old," the CDC said in an email to reporters. "Bearded dragons are not recommended as pets for children younger than 5, adults aged 65 or older, and people with weakened immune systems because these people are more likely to get a serious illness from germs that reptiles carry."

"Bearded dragons are not recommended as pets for children younger than 5, adults aged 65 or older, and people with weakened immune system

The CDC warned that pet dragons can shed Salmonella through feces even when appearing healthy. Contact between pet dragons and children 5 and under should be avoided if possible because of the risk of illness.

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Feds award $500 million for developing spray, pill COVID vaccines - University of Minnesota Twin Cities

(Precision Vaccinations News)

The U.S. Biomedical Advanced Research and Development Authority (BARDA) today announced up to $500 million in Project NextGen funding formultiple Phase 2b clinical trials to evaluatenovel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.

While currently approved COVID-19 vaccines are administered intramuscularly, they are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose, and gut, where the SARS-CoV-2 coronavirus first enters people.

Successful development of intranasal and oral vaccines would provide safe, effective, needle-free, easier-to-administer options with the potential to improve vaccine access.

We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness, U.S. HHS Secretary Xavier Becerra said in a press release on June 13, 2024.

The project awards were made to:

Up to $453 million to Vaxart of San Francisco, California, developing an oral pill vaccine candidate, adenovirus serotype 5. BARDA will provide an initial $65.7 million for early trial milestones, with remaining funds provided as the effort successfully advances toward trial execution. Vaxart will execute its own Phase 2b clinical trials.

Approximately $34 million was donated to Castlevax, part of the Mount Sinai Health System in New York City, to develop an intranasal vaccine candidate, CVAX-01.

Approximately $40 million will go to Cyanvac of Athens, Georgia, to develop an intranasal vaccine candidate, CVXGA.

Castlevax and Cyanvac Phase 2b trials are in partnership with BARDAs Clinical Studies Network.

These awards are just one component of BARDAs Project NextGen medical countermeasures portfolio.To date, BARDA has leveraged more than $2 billion in Project NextGen funding to support the development of next-generation vaccines, treatments, and enabling technologies.

As of June 14, 2024, the U.S. government has approved three COVID-19 vaccines, while the World Health Organization has qualified 13 vaccines.

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$500 Million Awarded to Newer COVID-19 Vaccines Precision Vaccinations News - Precision Vaccinations

Over the course of the pandemic, weve learned that the COVID-19 virus changes rapidly, producing many variants, similar to the flu. As a result, COVID-19 vaccines like flu vaccines must be updated to align with dominant viral strains currently circulating. While public awareness of the need for an updated flu vaccine has been established for many years, low COVID-19 vaccine uptake rates over the past year suggest a potential gap in knowledge around the need for updated protection against COVID-19.

To help journalists cover these changes, the National Press Foundation will host an online briefing, COVID Vaccine Updates Explained, 11 a.m.-12 p.m. ET, July 24.

July 24, 2024, 11 a.m. - 12 p.m. ET

This free webinar, sponsored by CVEEP, will explore the basics of virology as well as the latest CDC Advisory Committee on Immunization Practices (ACIP) recommendations for the latest COVID-19 vaccine.

NPF wants to help journalists and their audiences better understand the future of COVID-19 in a post-pandemic world. Given the continued risk of severe infection and long COVID, journalists must be able to explain to the public the timing, availability and need for this updated vaccine ahead of the 2024-2025 respiratory illness season.

This is the third webinar supported by CVEEP, a partnership of more than 250 organizations established to serve as a trusted source of information and discussion among organizations representing a variety of communities that face challenges from infectious respiratory illness, particularly diverse communities that have been most harmed by the effects of respiratory illness. The most recent briefing on COVID antiviral treatments can be watched here:

Speakers for the July 24 briefing will be listed here as they are confirmed.

This webinar is sponsored by CVEEP. NPF is solely responsible for its content.

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REGISTER: COVID Vaccine Updates Explained Webinar July 24 - National Press Foundation